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Last Updated: June 4, 2020

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VISTOGARD Drug Profile


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When do Vistogard patents expire, and what generic alternatives are available?

Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

US ANDA Litigation and Generic Entry Outlook for Vistogard

Vistogard was eligible for patent challenges on September 4, 2019.

Indicators of Generic Entry

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Summary for VISTOGARD
International Patents:175
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 57
Patent Applications: 60
Formulation / Manufacturing:see details
DailyMed Link:VISTOGARD at DailyMed
Drug patent expirations by year for VISTOGARD
Pharmacology for VISTOGARD
Synonyms for VISTOGARD
(2R,3R,4R,5R)-2-(ACETOXYMETHYL)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1(2H)-YL)TETRAHYDROFURAN-3,4-DIYL DIACETATE
105T388
2 ,3 ,5 -Triacetyluridine
2',3',5'-Tri-O-acetyluridine
2',3',5'-Tri-O-acetyluridine, >=98%
2',3',5'-Triacetyluridine
293738-13-3
2WP61F175M
4-Hydroxy-1-(2,3,5-tri-O-acetylpentofuranosyl)pyrimidin-2(1H)-one
4105-38-8
AK-73070
AKOS015964563
ANW-29551
API0001026
AUFUWRKPQLGTGF-FMKGYKFTSA-N
AX8007900
CHEBI:90914
CHEMBL2107381
CS-D1799
CTK3J5861
D09985
DB09144
DTXSID70951914
EINECS 223-881-5
FT-0081134
HY-14905
J-700012
KSC495Q6D
MFCD00023795
MLS006009982
PN 401
PN-401
PN401
PubChem14176
Q22075857
RG 2133
RG-2133
RG2133
s6484
SB18970
SCHEMBL871011
SMR004701034
Tri-O-acetyluridine
triacetyl uridine
Triacetyluridine
UNII-2WP61F175M
URI007
Uridine 2',3',5'-triacetate
Uridine triacetate
Uridine triacetate (USAN/INN)
Uridine triacetate [USAN:INN]
Uridine, 2',3',5'-triacetate
Vistogard (TN)
Vistonuridine
Xuriden
Xuriden (TN)
ZINC3843198

US Patents and Regulatory Information for VISTOGARD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VISTOGARD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 2017/033 Ireland   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 1790063-0 Sweden   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
1849470 17C1028 France   Start Trial PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 CA 2017 00036 Denmark   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470 2017C/028 Belgium   Start Trial PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 LUC00036 Luxembourg   Start Trial PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Moodys
McKesson
AstraZeneca
Mallinckrodt

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